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Assisted Movement Neuro-rehabilitation: VA Multi-site Clinical Trial

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ClinicalTrials.gov Identifier: NCT00223808
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cerebrovascular Disorders
Hemiplegia
Interventions Other: Robot-Low
Other: Robot-High
Other: Control
Enrollment 71
Recruitment Details Enrollment: November 2002 - December 2004 Enrollment sites: Michael E. DeBakey VA Medical Center, Houston, TX; VA Greater Los Angeles Healthcare System, Los Angeles, CA; and VA Palo Alto Health Care System, Palo Alto, CA. Data analysis site: Central Texas Veterans Health Care System, Temple, TX.
Pre-assignment Details 4 subjects excluded from group assignment due to medical conditions that precluded moderate-workload exercise.
Arm/Group Title Robot-Low Robot-High Control
Hide Arm/Group Description Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
Period Title: Overall Study
Started 22 22 23
Completed 19 [1] 17 [1] 18 [1]
Not Completed 3 5 5
Reason Not Completed
<5 hrs therapy before discharge             3             5             5
[1]
Completed at least the immediate post-treatment testing with 5 or more hours of treatment.
Arm/Group Title Robot-Low Robot-High Control Total
Hide Arm/Group Description Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot Total of all reporting groups
Overall Number of Baseline Participants 22 22 23 67
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 23 participants 67 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
16
  72.7%
19
  86.4%
10
  43.5%
45
  67.2%
>=65 years
6
  27.3%
3
  13.6%
13
  56.5%
22
  32.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 22 participants 23 participants 67 participants
62.95  (8.34) 59.04  (9.30) 67.87  (12.56) 63.36  (10.75)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 22 participants 23 participants 67 participants
Female
0
   0.0%
1
   4.5%
0
   0.0%
1
   1.5%
Male
22
 100.0%
21
  95.5%
23
 100.0%
66
  98.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 22 participants 23 participants 67 participants
22 22 23 67
1.Primary Outcome
Title Fugl-Meyer Score Change Immediately Following Study Intervention.
Hide Description Change in Fugl-Meyer Assessment (FMA) score. The FMA evaluates motor function, sensation, balance, and joint function in hemiplegic patients and provides a cumulative numerical score. It is widely used to evaluate changes in function over time in clinical care and therapeutic trials following stroke. Five domains can be assessed, including motor function (upper and lower limbs); sensory function; balance; joint range of motion; and joint pain. Items within each domain are scored on a 3-point ordinal scale: 0 = cannot perform; 1 = performs partially; and 2 = performs fully. Subscales can be administered without the using the full test. For the upper limb motor function subscale used in this clinical trial, 33 items were evaluated, each rated on a 3-point scale (0-2), then summed for a maximum possible score of 66. A greater increase in the score represents a greater improvement in upper limb motor function.
Time Frame After study intervention (on completion of the maximum planned number of sessions for their group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-Low Robot-High Control
Hide Arm/Group Description:
Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
Overall Number of Participants Analyzed 19 17 18
Mean (Standard Error)
Unit of Measure: units on a scale
6.8  (1.9) 14.4  (3.6) 14.0  (3.6)
2.Primary Outcome
Title Fugl-Meyer Score Change at 6 Months
Hide Description Change in Fugl-Meyer score at 6-months from study enrollment compared to baseline. Maximum score = 66.
Time Frame FMA at 6 months from study enrollment compared to baseline FMA performed prior to study intervention, which began between 7 and 21 days post-stroke.
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 37 subjects returned for the 6-month follow-up evaluations.
Arm/Group Title Robot-Low Robot-High Control
Hide Arm/Group Description:
Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
Overall Number of Participants Analyzed 14 11 12
Mean (Standard Error)
Unit of Measure: units on a scale
15.9  (3.5) 23.6  (5.8) 15.3  (4.9)
3.Secondary Outcome
Title Change in FIM Score Immediately Following Study Intervention.
Hide Description Change in the upper limb portion of the Functional Independence Measure (FIM) was assessed to determine treatment impact on independence in activities of daily living (ADL). The FIM indicates the level of disability based on how much assistance is required for an individual to carry out ADL. It can be used to assess13 motor and 5 cognitive tasks, each rated on a 7 point ordinal scale (0 = total assistance or complete dependence; 7 = complete independence in the task). Tasks include For this study, a subset of 9 tasks involving the upper limbs was used (maximum score = 63). A greater change represents a greater improvement in independence carrying out tasks requiring functional use of the upper limbs.
Time Frame After study intervention (on completion of the maximum planned number of sessions for each group or discharge from inpatient rehabilitation, whichever came first) compared to baseline at study enrollment between 7 and 21 days post-stroke.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robot-Low Robot-High Control
Hide Arm/Group Description:
Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
Overall Number of Participants Analyzed 19 17 18
Mean (Standard Error)
Unit of Measure: units on a scale
17.7  (1.9) 21.5  (2.1) 15.9  (1.5)
4.Secondary Outcome
Title Change in FIM Score at 6-months
Hide Description

Change in FIM score at 6-months from study enrollment compared to baseline. Maximum score = 63

.

Time Frame Change in FIM score at 6-months from study enrollment compared to baseline FIM prior to study intervention, which began between 7 and 21 days post-stroke.
Hide Outcome Measure Data
Hide Analysis Population Description
A total of 37 subjects returned for the 6-month follow-up evaluations.
Arm/Group Title Robot-Low Robot-High Control
Hide Arm/Group Description:
Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
Overall Number of Participants Analyzed 14 11 12
Mean (Standard Error)
Unit of Measure: units on a scale
24.2  (2.9) 27.5  (3.0) 26.8  (3.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Robot-Low Robot-High Control
Hide Arm/Group Description Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
All-Cause Mortality
Robot-Low Robot-High Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
Robot-Low Robot-High Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/23 (0.00%)   0/22 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Robot-Low Robot-High Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/23 (0.00%)   0/22 (0.00%) 
Limitations include the relatively small number of subjects in each group and the variation in severity level across subjects. Subjects at the Houston site were enrolled earlier after stroke than in the LA site and the Palo Alto site.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles Burgar, MD
Organization: CTVHCS
Phone: 254/743-0085
EMail: charles.burgar1@va.gov
Layout table for additonal information
Responsible Party: VA Office of Research and Development ( US Department of Veterans Affairs )
ClinicalTrials.gov Identifier: NCT00223808    
Obsolete Identifiers: NCT00038324
Other Study ID Numbers: B2695-I
First Submitted: September 14, 2005
First Posted: September 22, 2005
Results First Submitted: October 9, 2013
Results First Posted: February 17, 2014
Last Update Posted: February 17, 2014